Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-01-06 @ 1:09 PM
Study NCT ID:
NCT04795895
Status:
TERMINATED
Last Update Posted:
2024-07-19
First Post:
2021-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'whyStopped': 'No obvious difference of primary outcome was detected when external reviewing', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-10', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correct rate as comparing with the chest radiography in each group', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Point-of-care ultrasound,ultrasound'], 'conditions': ['Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology.\n\nAim: Find the best strategy to confirm gastric tube placement to avoid immediate complication.\n\nMethod: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical indication of nasogastric tube placement\n* Age than 20 years old.\n\nExclusion criteria:\n\n* Facial trauma or head-base fractures\n* Esophageal or gastric resection\n* Esophageal strictures or alkaline injury\n* Open wound in the area to prevent ultrasonography'}, 'identificationModule': {'nctId': 'NCT04795895', 'briefTitle': 'Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, a Randomization Trial', 'orgStudyIdInfo': {'id': '201907167RINB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultrasonography (US)', 'interventionNames': ['Diagnostic Test: ultrasonography (US)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard routine (SR)', 'interventionNames': ['Diagnostic Test: Standard routine (SR)']}], 'interventions': [{'name': 'ultrasonography (US)', 'type': 'DIAGNOSTIC_TEST', 'description': 'US evaluation was performed after insertion of the tube via subxiphoid approach for tube passing esophagogastric (EG) junction. The tube insertion procedure will be repeated no more than three attempts if no visualization by US.', 'armGroupLabels': ['ultrasonography (US)']}, {'name': 'Standard routine (SR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard routine (SR)', 'armGroupLabels': ['Standard routine (SR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'test3', 'city': 'Taipei', 'state': 'Test2', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ying-Chun Chien, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}